Agenda

If viewing on mobile, use horizontal orientation to view full width of agenda. 

Monday, March 11, 2019

TimeEventLocation
5:00-7:00 p.m.RegistrationConference Registration Desk
6:00-8:00 p.m.Networking ReceptionHill Atrium

Tuesday, March 12, 2019

TimeEventLocation/Speaker
7:00-8:30 a.m.Breakfast BuffetMagnolia Room
7:30-8:30 a.m.Late RegistrationConference Registration Desk
MORNING SESSION - Mahler Auditorium
8:30-8:45 a.m.Welcome and OrientationDean Kelly M. Smith & Michael Bartlett , University of Georgia
8:45-9:30 a.m.Update from the Office of Regulatory AffairsAlonza Cruse, FDA ORA
9:30-9:45 a.m.Q&A Panel
9:45-10:15 a.m.Networking BreakHill Atrium
10:15-11:00 a.m.Assuring GXP Data Integrity – CybersecurityAnil Sawant, Merck
11:00-11:45 a.m.Compliance Trends and Issues for the Generic IndustryDan Barreto, Teva
11:45 a.m. - 12:00 p.m.Q&A Panel
12:00-1:00 p.m.Networking LunchMagnolia Room
AFTERNOON SESSION - Mahler Auditorium
1:00-1:45 p.m.What Practical Impact Will Brexit Have? A view from pharma companiesTor Gråberg, AstraZeneca
1:45-2:30 p.m.Update from PDA Task Force on Data IntegrityRonald Tetzlaff, Parexel
2:30-2:45 p.m.Q&A Panel
2:45-3:15 p.m.Networking BreakHill Atrium
3:15-4:00 p.m.Quality Metrics and Operational Excellence: Bringing together what belongs together — Insights from a Decade of ResearchThomas Friedli, University of St. Gallen
4:00-4:45 p.m.Controlling Human Error in the Manufacturing FloorGinette Collazo, Human Error Solutions
4:45-5:00 p.m.Q&A Panel
6:30-8:30 p.m.Dinner
"Universal Influenza Vaccines"
Magnolia Room
Ted Ross, University of Georgia

Wednesday, March 13, 2019

TimeEventLocation/Speaker
7:00-8:15 a.m.Breakfast BuffetMagnolia Room
MORNING SESSION - Mahler Auditorium
8:15-9:00 a.m.Making Better Decisions in a Regulated
Environment — Cognitive Bias and Critical Thinking
William Mestrandrea, Celgene
9:00-9:45 a.m.Virtual Manufacturing ChallengesTed Wheeler, Aerie Pharmaceuticals
9:45-10:00 a.m.Q&A Panel
10:00-10:30 a.m.Networking BreakHill Atrium
10:30-11:15 a.m.Case Studies from GMP InspectionsIleana Barreto-Pettit, FDA ORA
11:15 a.m. - 12:00 p.m.Preparing for FDA Pre-Approval InspectionsJohnetta Walters, FDA ORA
12:00-12:15 p.m.Q&A Panel
12:15-1:15 p.m.Networking LunchMagnolia Room
AFTERNOON SESSION - Mahler Auditorium
1:15-2:00 p.m.Complaint Handling: How Far Should You Go?Jennifer Ahearn, Engineering Systems
2:00-2:45 p.m.Medical Product CommunicationsAlan Minsk, Arnall Golden Gregory LLP
2:45-3:00 p.m.Q&A Panel
3:00-3:30 p.m.Networking BreakHill Atrium
3:30-4:15 p.m.QRM in PQS: The Future ShapeEva Urban, Celgene, PDA Quality Group
4:15-5:00 p.m.Health Canada Inspection Trends and Case StudiesAnthony Lostracco, Health Canada
5:00-5:15 p.m.Q&A Panel
5:15-6:45 p.m.Networking Reception, joined by UGA graduate students and postdocsHill Atrium
Enjoy dinner in Athens!
See our Local Recommendations for inspiration for your night on the town.

Thursday, March 14, 2019

TimeEventLocation/Speaker
7:00-8:15 a.m.Breakfast BuffetMagnolia Room
MORNING SESSION - Mahler Auditorium
8:15-9:00 a.m.FDA Oversight of Drug CompoundingHidee Molina, FDA CDER
9:00-9:45 a.m.Cell and Gene Therapy Quality ConsiderationsVivianne Arencibia, QxP
9:45-10:00 a.m.Q&A Panel
10:00-10:30 a.m.Networking BreakHill Atrium
10:30-11:15 a.m.Elemental ImpuritiesMelissa Figgins, QxP
11:15 a.m. - 12:00 p.m.Ingredient Supplier QualificationMarie Mathews, FDA CDER
12:00-12:15 p.m.Q&A Panel
12:15 p.m.Conference Adjournment
POST-CONFERENCE TUTORIAL: Room R (Second Floor)
Session Coordinator: Trina von Waldner
12:15-1:00 p.m.Luncheon for Post-Conference Tutorial ParticipantsMagnolia Room
1:00-2:30 p.m.Trend Analysis and CAPA VerificationJennifer Ahearn, Engineering Systems
2:30-2:45 p.m.Networking BreakKellogg Concourse
2:45-4:00 p.m.Trend Analysis and CAPA Verification (continued)Bob Wittorf, Merck
4:00 p.m.Post-Conference Adjournment
Continuing Education (CE) credit available through this tutorial only.